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Effect of Keratinized Mucosa on Peri-implant Health

Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04861662
Enrollment
31
Registered
2021-04-27
Start date
2018-10-10
Completion date
2021-06-30
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Free Gingival Graft, Keratinized Mucosa

Brief summary

The aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery.

Detailed description

The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The patients who applied to the Department of Periodontology, received dental implant treatment, and required routine follow-up for the maintenance of peri-implant health will be included. Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI) measurements will be evaluated with the Williams periodontal probe. These measurements will be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and mid-lingual) and these four measurements will be averaged for each implant. In addition, the amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the mucosal margin and mucogingival junction on the vestibular surface with the same probe. After clinical examination, a periapical radiograph will be taken using a parallel technique to determine marginal bone loss surrounding the implant. The distance between the implant neck and the most coronal part of the alveolar crest will be measured on the mesial and distal surfaces for each implant on the obtained radiographs and the average of the two measurements will be taken. The parameters checked during clinical and radiographic examination will be compared between patients with or without keratinized mucosa and whose keratinized mucosa has been increased by free gingival graft.

Interventions

Free gingival graft procedure applied to implants with KM\<2 mm to increase the width of keratinized mucosa surrounding them

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Being over the age of 18 * Having dental implant treatment and prosthetic restoration * Not having received bone augmentation treatment at the implant site * To comply with maintenance controls after dental implant treatment

Exclusion criteria

* Pregnancy * Having used systemic antibiotics within 6 weeks prior to the start of the study * Having a disease that affects bone and soft tissue metabolism, such as hyperthyroidism, hyperparathyroidism, and uncontrolled diabetes mellitus * Using drugs that cause immunosuppression * Using a medicine that affects bone metabolism, such as a bisphosphonate

Design outcomes

Primary

MeasureTime frameDescription
Marginal bone lossBaseline, 3rd month, 6th month and 1st yearChange of marginal bone loss measured from periapical radiographs

Secondary

MeasureTime frameDescription
Modified bleeding indexBaseline, 3rd month, 6th month and 1st yearParameter showing peri-implant mucosa inflammation
Probing depthBaseline, 3rd month, 6th month and 1st yearThe depth of peri-implant sulcus in millimeters
Modified plaque indexBaseline, 3rd month, 6th month and 1st yearParameter showing oral hygiene performance

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026